ALARIS EXTENSION SET Adverse Event — Malfunction (MDR 9616066-2020-01509)
ALARIS EXTENSION SET Adverse Event — Malfunction (MDR 9616066-2020-01509) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ALARIS EXTENSION SET; Generic name: SET, ADMINISTRATION, INTRAVASCULAR; Manufacturer: CAREFUSION.
| Device | ALARIS EXTENSION SET |
|---|---|
| Generic name | SET, ADMINISTRATION, INTRAVASCULAR |
| Manufacturer | CAREFUSION |
| Report number | 9616066-2020-01509 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, OTHER |
| Narrative | IT WAS REPORTED THAT THERE WAS A TUBING CRACK WITH A LEAK. A QUADFUSE EXTENSION SET WAS IN USE ON AN UMBILICAL VENOUS CATHETER, WHEN A CRACK WITH A LEAK WAS OBSERVED AT THE "NAD." IT WAS NOTED THAT THE TUBING WAS CLAMPED OFF AND THE QUADFUSE EXTENSION SET WAS REPLACED. THE EVENT OCCURRED ON A PEDIATRIC UNIT. THERE WAS NO PATIENT HARM. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT INFORMATION WAS PROVI |
| Source | openFDA MAUDE (device adverse events) |
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